A PHASE I PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS (CCI779)

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Objectives are to access tolerability, safety, and to establish the MTD of CCI-779 (temsirolimus) in patients with varying degrees of hepatic dysfunction in order to provide appropriate dosing recommendation in this population. The pharmacokinetic profile will be characterized with varying degrees of hepatic function and the pharmacodynamic profile as measured by drug effects on various markers will be done. Toxicities and tumor response will be evaluated.